FDA staff reviewers found no major concerns about the accuracy and safety of Grail's blood test designed to detect more than 50 cancers ahead of an advisory committee meeting. The company's shares surged 35% on the news.
The U.S. Food and Drug Administration will convene its Molecular and Clinical Genetics Panel on September 23, 2026, to review Grail's premarket approval application for Galleri, a multi-cancer early detection test. The advisory committee meeting represents a critical regulatory milestone for the company, which anticipates a potential approval decision in early 2027.
The U.S. Food and Drug Administration will convene its Molecular and Clinical Genetics Panel on September 23, 2026, to review Grail's premarket approval application for Galleri, a multi-cancer early detection test. The advisory committee meeting represents a critical regulatory milestone for the company, which anticipates a potential approval decision in early 2027.
